ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
|
Back to Search Results |
|
Catalog Number B-2240 |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problems
Bacterial Infection (1735); Erosion (1750); Inflammation (1932); Pain (1994); Impaired Healing (2378)
|
Event Date 12/12/2014 |
Event Type
Injury
|
Event Description
|
Healthcare professional reported "patient presented at er", "complains of pain over port site", "has two areas of exposed device", "small amount of purulent fluid as well as fibrinous tissue surrounding the port consistent with a chronic indolent infection, "dense capsule" and "some mild inflammation down the tubing the buckle." the entire device was removed.
|
|
Manufacturer Narrative
|
(b)(4).Taper ii.Medwatch sent to fda on: 04/01/2015.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon the model number and implant date provided by the reporter the connector type is assumed to be a taper ii.Visual examination may determine the connector type associated with this report.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Pain, gastric erosion, infection, inflammation, and exposure are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional information has been reported to allergan regarding the diagnostic testing.
|
|
Manufacturer Narrative
|
Medwatch sent to fda on: 07/13/2015.Visual examination of the returned device determined the access port tubing connector to be a rapidport ez strain relief.Analysis noted signs of erosion, discoloration, and acid degradation.Analysis noted a striated opening at the buckle, and shell/ring described as surgical damage.Analysis noted the band tubing was broken with striations consistent with surgical end cuts to remove the device.
|
|
Search Alerts/Recalls
|
|
|